Home / Recalls / Medical Devices
SIGHT DIAGNOSTICS LTD recalls Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the
Recalled July 3, 2024 · FDA recall Z-2173-2024 · SIGHT DIAGNOSTICS
Hazard
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification. · FDA Class II
Units
7,450 units (2,800 US, 4,650 OUS)
Sold at
Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
Description
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
Product
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Manufacturer(s)
SIGHT DIAGNOSTICS LTD
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →